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18F-FDG Recurrent prostate cancer Published data Cardiac Oncologic 13N-ammonia (cardiac) 11C-choline 18F-fluciclovine 68Ga-DOTATATE (SSR+ NET) Selection criteria Truth standard and imaging outcome established for each patient Prospective Patient characteristics described Image interpretation methods described Truth standard detailed for each patient Methods for minimizing bias applied (e.g., masking, description of any patient or image selection bias) Images compared with pathology truth standard Prospective Eligibility criteria defining clinically applicable patient population described Endpoints clearly defined Data on study findings detailed Methods for minimizing bias applied (e.g., masking, randomization, multiple independent interpreters) Sample > 50 Images compared with truth standard of accepted myocardial perfusion method or coronary arteriography Prospective Endpoints clearly defined Eligibility criteria defined for clinically applicable patient population Study results detailed Methods for minimizing bias applied (e.g., masking, randomization) Prospective or retrospective Patient disposition adequately described Images compared with pathology truth standard Measures to control bias in image interpretation described Study drug dose described Analytic procedure described Noninformative conventional imaging results Sample ≥ 10 Site images available for reinterpretation Site data available for reanalysis Prospective or retrospective Patient disposition adequately described Images compared with truth standard of histopathology or clinical follow-up Image interpretation described Studies (n) 10 meeting all criteria 2 meeting all criteria; 16 variably meeting criteria 1 meeting all criteria; 3 meeting all criteria except retrospective design 2 prospective and 2 retrospective 2 prospective 2 retrospective Patients (n) 298 1,311 (including 155 in the studies meeting all criteria) 293 (including 193 in study meeting all criteria) 98 201 167 Observations Sensitivity and specificity Sensitivity and specificity Sensitivity and specificity Sensitivity and specificity T/F positives and negatives; agreement with comparator T/F positives and negatives SSR+ NET = somatostatin receptor–positive neuroendocrine tumor; T/F = true and false.
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- Article
- Abstract
- FDA GUIDANCE ON THE USE OF PUBLISHED LITERATURE TO ESTABLISH DRUG EFFECTIVENESS
- PRECEDENT FOR IMAGING DRUG APPROVAL BASED ON PUBLISHED REPORTS
- AN EXPLORATION OF PUBLISHED REPORTS TO POTENTIALLY SUPPORT APPROVAL OF A NEW IMAGING AGENT
- CONCLUSIONS AND RECOMMENDATIONS
- APPENDIX A
- DISCLOSURE
- Footnotes
- REFERENCES
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